Xeloda Plus Paclitaxel in Gastric Cancer With Liver Metastasis
Neoadjuvant Chemotherapy With Xeloda in Combination With Paclitaxel in Gastric Cancer With Liver Metastasis
1 other identifier
interventional
60
1 country
1
Brief Summary
To investigate the efficacy of capecitabine combined with paclitaxel as neoadjuvant chemotherapy for gastric cancer with liver metastasis only
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 gastric-cancer
Started Aug 2009
Typical duration for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 22, 2010
July 1, 2010
4.3 years
July 21, 2010
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided
Primary Endpoint is PFS (progression free survival), tumor response will be evaluated using RECIST criteria. Survival data will be analyzed by Kaplan Meier method. 95% CI will be provided.
3 years from last patient enrolled
Study Arms (1)
CAPECITABINE
EXPERIMENTALSingle arm: Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; repeat three cycles (approximately 3- months);
Interventions
Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months);
Eligibility Criteria
You may qualify if:
- Ambulatory males or females, aged no less than 18 years.
- ECOG performance status: 0-1.
- Histologically confirmed gastric adeno-carcinoma.
- Radiologically confirmed liver metastasis without other distant metastasis.
- No serious concomitant medical illnesses
- Life expectancy more than 3 months
- Be willing and able to comply with the protocol for the duration of the study
- No Prior treatment for metastatic disease
- Give signed informed consent
You may not qualify if:
- not able to comply with the protocol
- with high risks which may compromise the benefit of proposed regimen
- Active (significant or uncontrolled) gastrointestinal bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Cancer Hospital & Institutelead
- Roche Pharma AGcollaborator
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100036, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiafu Ji, Post-Doctor
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 22, 2010
Study Start
August 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
July 22, 2010
Record last verified: 2010-07